BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE 7900

    MDR report key: 5996295 · Received October 4, 2016

    Report

    Report Number
    2112667-2016-01936
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 8, 2016
    Report Date
    October 4, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K050626
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE EQUIPMENT AND CONFIRMED THE REPORTED COMPLAINT. THE BAG/VENT SWITCH WAS REPLACED, AND THE UNIT WAS RETURNED TO SERVICE. PATIENT INFORMATION COULD NOT BE OBTAINED AFTER MULTIPLE ATTEMPTS. ATTEMPTS WERE MADE AS FOLLOWS: ON (B)(6) 2016 PHONE CALL, (B)(6) 2016 PHONE CALL, (B)(6) 2016 PHONE CALL.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE UNIT WOULD INTERMITTENTLY BE UNABLE TO SWITCH TO MANUAL VENTILATION WHEN REQUESTED DURING A CASE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648154 AESPIRE 7900 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC. 1009-9012-000

    Patients

    Seq Age Sex Outcome Treatment
    1